510(k) Report

510(k) · Cleared

Recalled · Class II · 2016

Aquilion Lightning (TSX-035A/2, V7.0)

K151833510(k) TraditionalCleared Oct 9, 201595-day reviewClass II21 CFR 892.1750Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Toshibamedical Systems Corporation · JAK System, X-Ray, Tomography, Computed

Cleared on Oct 9, 2015 as substantially equivalent to K121553 (Toshibamedical Systems Corporation, 2012) after a 95-day review. Its family tree reaches back 2 generations to 2010. 11 later devices descend from it. It has been recalled once.

Decided
Oct 9, 2015
Review
95 days
Class
Class II
Product code
JAK
Recalls
1
Predicates
1

Its longest line of descent runs back 2 generations to K093891 (2010). 11 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2016: 1 descendant cleared2017: 2 descendants cleared2021: 2 descendants cleared2020: 2 descendants cleared2023: 3 descendants cleared2026: 1 descendant clearedK093891 · Aquilion One Version 4.6 W/Dual Energy Scan System, Model TSX-301A/2 · Toshibamedical Systems Corporation · 2010 · recalledK121553 · Aquilion RXL · Toshibamedical Systems Corporation · 2012 · recalled2010201520202025
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 1 descendant3 generations forward: 2 descendants4 generations forward: 2 descendants5 generations forward: 2 descendants6 generations forward: 2 descendants7 generations forward: 1 descendant K121553 · Aquilion RXL · Toshibamedical Systems Corporation · 2012 · recalledK093891 · Aquilion One Version 4.6 W/Dual Energy Scan System, Model TSX-301A/2 · Toshibamedical Systems Corporation · 2010 · recalled0+5
  1. Root · 2 generations backK093891 Aquilion One Version 4.6 W/Dual Energy Scan System, Model TSX-301A/2Toshibamedical Systems Corporation · 2010 · Recalled
  2. 1 generation backK121553 Aquilion RXLToshibamedical Systems Corporation · 2012 · Recalled
  3. This deviceK151833 Aquilion Lightning (TSX-035A/2, V7.0)Toshibamedical Systems Corporation · 2015
  4. Descendant · cites it directly · 10 of its ownK153263 Aquilion Lightning, TSX-035A/4 and /5, V7.0Toshibamedical Systems Corporation · 2016
  5. Descendant · 2 generations on · 9 of its ownK170019 Aquilion Lightning, TSX-036A/1, V8.4Toshibamedical Systems Corporation · 2017 · Recalled
  6. Descendant · 3 generations on · 4 of its ownK201836 Aquilion Lightning (TSX-036A/7) V10.2 with AiCE-iCanon Medical Systems Corporation · 2021
  7. Descendant · 4 generations on · 3 of its ownK222819 Aquilion Serve (TSX-307A/1) V1.2 with AiCE-iCanon Medical Systems Corporation · 2023
  8. Descendant · 3 generations on · 3 of its ownK172188 Aquilion Prime SP, TSX-303B/1, v8.4Toshiba Medical Systems Coroporation · 2017 · Recalled

Showing 5 of 11 descendants. See all descendants

Descendants cleared per year

2016: 12017: 22020: 22021: 22023: 32026: 1
2016high 3 (2023) · low 0 (2018)2026

Most influential descendants

Showing 5 of 11 · See all
  • K153263Aquilion Lightning, TSX-035A/4 and /5, V7.0Toshibamedical Systems Corporation · 2016 · cites it directly10descendants
  • K170019Aquilion Lightning, TSX-036A/1, V8.4Toshibamedical Systems Corporation · 2017 · 2 generations on9descendants
  • K201836Aquilion Lightning (TSX-036A/7) V10.2 with AiCE-iCanon Medical Systems Corporation · 2021 · 3 generations on4descendants
  • K222819Aquilion Serve (TSX-307A/1) V1.2 with AiCE-iCanon Medical Systems Corporation · 2023 · 4 generations on3descendants
  • K172188Aquilion Prime SP, TSX-303B/1, v8.4Toshiba Medical Systems Coroporation · 2017 · 3 generations on3descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K093891Aquilion One Version 4.6 W/Dual Energy Scan System, Model TSX-301A/2Toshibamedical Systems Corporation20101
−1K121553Aquilion RXLToshibamedical Systems Corporation20121
0 (this device)K151833Aquilion Lightning (TSX-035A/2, V7.0)Toshibamedical Systems Corporation2015—
+1K153263Aquilion Lightning, TSX-035A/4 and /5, V7.0Toshibamedical Systems Corporation2016—
+2K170019Aquilion Lightning, TSX-036A/1, V8.4Toshibamedical Systems Corporation20171
+3K201836Aquilion Lightning (TSX-036A/7) V10.2 with AiCE-iCanon Medical Systems Corporation2021—
+4K222819Aquilion Serve (TSX-307A/1) V1.2 with AiCE-iCanon Medical Systems Corporation2023—
+3K172188Aquilion Prime SP, TSX-303B/1, v8.4Toshiba Medical Systems Coroporation20171

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201610
201720
202020
202120
202330
202610
FIG. 1 — Lineage of K151833, 2010–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in JAK? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new JAK device

  1. #1 K230223 iCAC Devicescore 23.5 · 12 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K121553Aquilion RXL
Summary page 5
…L, ToshibaAmerica Tomograph July26, 892.1750 90JAK K121553 TSXͲ101A MedicalSystems yXͲray 2012…
Toshibamedical Systems Corporation20121

Also cleared against K121553: 1 other device →

What descends from it? (11)

See all 11

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K153263Aquilion Lightning, TSX-035A/4 and /5, V7.0Toshibamedical Systems Corporation201610

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Apr 12, 2016Class IIZ-1560-2016Device DesignToshiba American Medical Systems, Inc. is recalling the TSX-035A because of a potential problem with the Aquilion Lightning CT System iStation cover falling off of the gantry.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 5 years and passes through 1 company; a new generation was cleared every 3.2 years on median.
  • 2 of the 2 ancestors have a recall of any class.
  • Of its descendants, K153263 (Toshibamedical Systems Corporation, 2016) has gone furthest, with 10 descendants of its own.
  • 1 other device also cites its predicate K121553.

How does its category compare?

All JAK devices

JAK System, X-Ray, Tomography, Computed: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.

FDA decisions per year · JAK

27in 2025

2007: 142008: 262009: 152010: 72011: 162012: 282013: 172014: 302015: 302016: 252017: 292018: 242019: 282020: 302021: 202022: 302023: 272024: 262025: 272026 (partial year): 21
2007high 30 (2014) · low 7 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JAK

141in 2025

2007: 27 days median2008: 42 days median2009: 31 days median2010: 92 days median2011: 155 days median2012: 121 days median2013: 132 days median2014: 200 days median2015: 140 days median2016: 129 days median2017: 96 days median2018: 114 days median2019: 94 days median2020: 112 days median2021: 145 days median2022: 131 days median2023: 139 days median2024: 141 days median2025: 141 days median2026 (partial year): 167 days median
2007high 200 (2014) · low 27 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · JAK

17in 2025

2007: 112008: 162009: 292010: 512011: 342012: 232013: 112014: 102015: 282016: 442017: 332018: 102019: 52020: 82021: 152022: 92023: 92024: 202025: 172026 (partial year): 23
2007high 51 (2010) · low 5 (2019)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JAK

219in 2025

2007: 762008: 1202009: 1052010: 1192011: 2052012: 1922013: 4142014: 3082015: 4542016: 3652017: 3382018: 5432019: 2332020: 1772021: 2612022: 1992023: 3102024: 2122025: 219
2007high 543 (2018) · low 76 (2007)2025

MAUDE reports naming product code JAK, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200714271176
2008264216120
2009153129105
201079251119
20111615534205
20122812123192
20131713211414
20143020010308
20153014028454
20162512944365
2017299633338
20182411410543
201928945233
2020301128177
20212014515261
2022301319199
2023271399310
20242614120212
20252714117219
20262116723—

What is it indicated for?

This device is indicated to acquire and display cross-sectional volumes of

the whole body, to include the head.

The Aquilion Lightning has the capability to provide volume sets. These

volume sets can be used to perform specialized studies, using indicated

software/hardware, by a trained and qualified physician.

Indications for use as stated in the FDA summary.

Also cleared against K121553

1 other device cites the same predicate.

  • K190505Low Dose Lung Screening OptionCanon Medical Systems Corporation · 2019

More from Toshibamedical Systems Corporation

80 FDA decisions under this applicant name. See the company

  • K173962Viamo c100 TUS-VC100 Diagnostic Ultrasound SystemToshibamedical Systems Corporation · 2018
  • K173468Aquilion Precision (TSX-304A/2) V8.6 with FIRST 3.0Toshibamedical Systems Corporation · 20181 recall
  • K173088Vitrea Software Toshiba Package VSTP-001AToshibamedical Systems Corporation · 2018
  • K173382Vantage Galan 3T, V4.6Toshibamedical Systems Corporation · 2018
  • K173090Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V2.4Toshibamedical Systems Corporation · 2018

Recent decisions in JAK

The JAK category page

  • K260391AVIEW Aorta MetricsCoreline Soft Co., Ltd. · 2026
  • K261225CAS-One IRCascination AG · 2026
  • K261125BodyTom 64 (NL4100); OmniTom Elite (NL5000)Samsung HME America, Inc., dba NeuroLogica Corp. · 2026
  • K261229SCENARIA View Phase 6.0Fujifilm Corporation · 2026
  • K253836FCT iStream Phase 2Fujifilm Corporation · 2026

https://510kreport.com/device/K151833 · printed Nov 6, 2026

Cite this page

510(k) Report. “K151833: Aquilion Lightning (TSX-035A/2, V7.0).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151833

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026